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Guiding Principles for Leveraging at FDA
(Draft)

FDA invites the public to comment on these draft Guiding Principles for Leveraging at FDA. We intend to use these principles to guide us as we explore and implement new collaborative ventures with academia, health providers, other government agencies, regulated industry, and, of course, consumers, so your comments are very important to us. You can send us your comments.

By choosing to work with other organizations that share our public health and safety goals, FDA can significantly amplify its public health impact, leverage the intellectual capital of others, and make wise use of its resources. FDA has been quite successful with its past collaborations and the agency intends to expand and build upon this solid foundation in developing new partnerships.

What is leveraging? Leveraging is the creation of relationships and/or formal agreements with others outside the FDA that will ultimately enhance FDA's ability to meet its public health mission. Leveraging is a continuum.

The guiding principles for leveraging at FDA are:

1. Leveraging can produce greater net benefits, e.g., by sharing talent and material resources and achieving results through synergism.
2. Successful leveraging provides benefits and incentives for all participants. In addition to FDA this may include consumers, industry, academia, health providers, and other government agencies. In particular, leveraging efforts should increase consumer confidence in regulated products.
3. Successful leveraging requires
   • identification of tasks to be accomplished
   • identification of partners with whom we share goals
   • agreement on the roles of each partner in accomplishing those tasks
   • shared responsibility for obtaining and evaluating results
   • an open and credible process for those parties involved
   • recognizing accomplishments
4. Leveraging must work within established FDA legal authority.
5. FDA's status as a scientific regulatory agency requires an added dimension of due diligence and management of leveraged relationships by professionals at all levels within the agency.
6. Leveraging activities should not
   • compromise the Agency's commitment to high standards in terms of timeliness, predictability, and quality of our science and decision making,
   • jeopardize FDA's role as an independent, impartial scientific agency,
   • result in the occurrence or the appearance of a conflict of interest, or
   • be seen as a means to avoid or off-load work and responsibilities or merely as a response to an inadequate budget.
7. Leveraging can be accomplished through a wide variety of collaborative arrangements, both formal and informal. December 13, 1999.

How Will FDA Look in Five Years In Regard to Outside Leveraging?

• Seeking out partners with shared interests -- FDA will look first to those with shared interests to assist in addressing emerging issues or concerns. We will move away from "FDA first and only" and toward an approach that also seeks out willing and capable partners.
• Considering partners early in the process -- All staff throughout FDA, when recognizing an issue or concern, will first ask, "Who, in addition to FDA, shares an interest in addressing this?"
• Developing courses of action together -- FDA will vigorously pursue collaborations from the first stages of identifying a shared issue or concern, devising possible solutions, and selecting the most expeditious and efficient course of action.
• Defining the broader issues -- FDA will share its knowledge to help define critical public health issues even if FDA has little or no direct responsibility for addressing that issue today.
• Partners seek-out FDA's involvement -- Partners from industry, health providers, academia, other government agencies, and consumer groups will bring problems of public health significance to FDA and eagerly work together to solve them.
• Partners and FDA contacts -- A compendium of potential partners will be maintained to enable expeditious leveraging.
• Partnerships yield long-term benefits -- Outside leveraging opportunities will provide long term remedies to some of the most complex public health issues facing the Agency.
• Increased consumer confidence -- Leveraging efforts will increase consumer confidence in FDA's public health protection role.
• Commitment to mutual recognition -- When describing or reporting successes through collaboration, FDA and any partners will expressly recognize each other's contributions.

FDA's Current Vision Supports a Leveraging Commitment

The following components of FDA's Vision Statement support outside leveraging.

FDA is:

• An enabling agency - it stewards needed products and promotes public health.
• A collaborative agency - it strengthens its ties to the domestic and international scientific, health provider, and regulatory communities.
• A high-performance agency - it capitalizes on state-of-the-art information and communication technologies and management systems to enhance performance.

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